There are many updates to ISO 10993-1 a few of which can significantly impact how devices are assessed, one big change is requiring foreseeable misuse to be evaluated.
Foreseeable misuse is the use of a medical device by the user in a way not intended by the manufacturer, whether intentional or unintentional. Failure to consider misuse of a medical device may result in inaccurate categorization of components or the medical devices themselves, leading to inaccurate evaluations and insufficient tests.
The aim of this presentation is to discuss reasonable foreseeable misuse per ISO 14971 and how to incorporate it into biocompatibility evaluations per ISO 10993-1.
In this webinar, we will:
- Provide a brief overview of impactful updates to ISO 10993-1.
- Explain the risk assessment, ISO 14971 risk management and the likelihood of harm for the hazard.
- Have a discussion about what is foreseeable misuse using case studies and examples of conservative and non-conservative approaches.
Learn more about the presenters below.
